Effects of Calcium-Containing Oral Sprays on Fluorescence-Detectable Plaque Area in Children

NCT07269730 — Not applicable, Completed, 15 participants, Tri-Service General Hospital (TSGH)

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Effects of Calcium-Containing Solutions on Fluorescence-Detectable Plaque Area : An Exploratory Clinical Study

Registry	NCT07269730
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	15 (Actual)
Sponsor	Tri-Service General Hospital (TSGH) (Other)
Conditions	Dental Caries Tooth Demineralization, Early Childhood Caries (ECC)
Interventions	oral spray (Other)
Dates	start 2023-06-11, primary completion 2024-08-05, completion 2025-11-11, first posted 2025-12-08, last updated 2026-08-21
Locations	1 site in Taiwan

-Summary

This exploratory randomized clinical trial aimed to evaluate the effects of calcium-containing oral sprays on the primary clinical outcome, fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF). Fifteen children were randomly assigned to placebo, Formula 1 (a calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate, and 0.01% mesoporous bioactive glass), or Formula 2 (The same calcium-containing formulation supplemented with 225 ppm fluoride (0.05% NaF)) oral sprays for two months. Secondary outcomes included salivary calcium concentration and exploratory plaque microbiome analysis.

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+Detailed description

Calcium-containing biomimetic materials have been investigated as adjunctive approaches for managing early enamel demineralization. This exploratory randomized clinical trial evaluated the effects of calcium-containing oral sprays on fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF). Fifteen children were randomly assigned to placebo, Formula 1 (a calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate, and 0.01% mesoporous bioactive glass), or Formula 2 (the same calcium-containing formulation supplemented with 225 ppm fluoride (0.05% NaF)) oral sprays for two months. The primary clinical outcome was fluorescence-detectable plaque-associated area measured by QLF. Secondary outcomes included salivary calcium concentration measured using the arsenazo III colorimetric assay, and exploratory plaque microbiome analysis using 16S rRNA gene sequencing.

+Arms and interventions

Arm	Type	Interventions	Description
Placebo oral spray	Placebo comparator	Other: oral spray	Patient receiving oral sprays containing baseline ingredient solution for more than 2 months.
Formula 2 (Formula 1 plus 225 ppm fluoride) oral spray	Active comparator	Other: oral spray	Patient receiving oral spays containing the calcium-containing formulation supplemented with 225 ppm fluoride (0.05% NaF) for more than 2 month.
Formula 1 (Calcium-containing oral spray containing 0.3% calcium lactate, 0.01% dicalcium phosphate)	Experimental	Other: oral spray	Patient receiving Calcium-containing oral spray (0.3% calcium lactate, 0.01% dicalcium phosphate, and 0.01% mesoporous bioactive glass) for more than 2 months.

oral spray (Other): Calcium-containing oral spray

+Outcome measures

Primary outcomes

Fluorescence-detectable plaque-associated area measured by quantitative light-induced fluorescence (QLF) [Baseline and 2 months after initiation of the intervention.]: Fluorescence-detectable plaque-associated area was assessed using quantitative light-induced fluorescence (QLF). QLF images were obtained before and after the two-month intervention, and the fluorescence-detectable plaque-associated area was quantified as a percentage of the assessed tooth area.

Secondary outcomes

Salivary calcium concentration [Baseline and 2 months after initiation of the intervention.]: Saliva samples collected during the clinical trial were centrifuged at 3,000 rpm for 10 minutes to obtain the clarified supernatant, which was then diluted tenfold for calcium measurement. Salivary calcium concentration was measured in unstimulated whole saliva using an arsenazo III colorimetric assay.

Other outcomes

Exploratory outcome: plaque microbiome [Baseline and 2 months after initiation of the intervention.]: Exploratory plaque microbiome analysis was performed in three of the 15 participants before and after treatment. Plaque samples were collected using a periodontal probe and stored at -80°C. Bacterial DNA was extracted, and the V3-V4 regions of the 16S rRNA gene were analyzed by 16S rRNA gene sequencing. Taxonomic classification was performed using the SILVA 138 reference database and the Ribosomal Database Project (RDP).

+Eligibility

Sex: All, ages: 3 Years to 15 Years

Inclusion Criteria:

Required participants to have an ICDAS code ≥ 1 and ≤ 3 as determined by a clinician.

Exclusion Criteria:

1. Patient has received caries removal and restoration.
2. Patient has received fluoridation within 3 months.
3. The parents do not agree to participate in the study.
4. Patient has ICDAS code 4 - code 6

+Locations (1)

Facility	City	Country	Status
Tri-Service General Hospital	Taipei, Taiwan	Taiwan

+Publications

Results publication: Lin ZY, Fu E, Li CH, Chang TH, Yuh DY. Effects of calcium-containing solutions on fluorescence-detectable plaque area and enamel mineral volume: an in vitro and exploratory clinical study. BMC Oral Health. 2026 Sep 15;26(1):1873. doi: 10.1186/s12903-026-09789-z. PMID 42816839